(57 days)
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Micro Hematocrit Centrifuge
Operations Manual
Battery Charger
100 Micro Capillary/Micro Capillary Holders (heparinized)
General Laboratory Device
Methodology: Centrifugal
Measures Hematocrit
Battery Operated
Portable, Hand-Held
Safety Features: (1) Cover Lock (2) Low Battery Charge Indicator (3) Motor failure indicator
Optically read (digital readout)
Uses plastic disposable
Range 14% to 57%
Operates at 10,000 RPM
RCF= 4260
Rotor Radius= 1.5 inches
Here's a breakdown of the acceptance criteria and study information for the Spuncrit™ device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a numerical or pass/fail format for specific performance metrics. Instead, it presents performance data in comparison to a predicate device (Compur M1100 Minicentrifuge) and demonstrates precision. The "conclusion" section suggests that the device's performance is deemed "substantially equivalent" to the predicate, implying that its performance within the tested ranges is acceptable.
Assuming "substantial equivalence" is the overarching acceptance criterion, we can infer performance targets from the predicate device specifications and the presented data.
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Substantial Equivalence) | Reported Device Performance (Spuncrit™) |
|---|---|---|
| Measurement Range (Hematocrit) | 10% to 80% (Predicate's range) | 14% to 57% (Device's calibrated range) |
| Measurement Range (Estimated Hemoglobin) | Not explicitly stated for predicate but likely similar clinical utility as hematocrit. | 12.2 g/dL to 18.2 g/dL (Normal range only) |
| Methodology | Centrifugal | Centrifugal |
| Readout Type | Manual, visual read (Predicate) | Optically read (digital readout) |
| Speed (RPM) | 11,500 RPM (Predicate) | 10,000 RPM |
| Relative Centrifugal Force (RCF) | 5396 (Predicate) | 4260 |
| Rotor Radius | 1.5 inches (Predicate) | 1.5 inches |
| Precision (Within-Run) - Hematocrit | Not explicitly defined as acceptance criteria, but predicate performs acceptably. | Physician Office #1 (Day 1): Level 1 SD 0.26, Cv 0.01; Level 2 SD 0.94, Cv 0.03; Level 3 SD 1.03, Cv 0.02 |
| Physician Office #1 (Day 7): Level 1 SD 0.77, Cv 0.04; Level 2 SD 0.63, Cv 0.02; Level 3 SD 0.63, Cv 0.02 | ||
| Physician Office #2 (Day 1): Level 1 SD 0.70, Cv 0.04; Level 2 SD 0.52, Cv 0.02; Level 3 SD 0.74, Cv 0.02 | ||
| Physician Office #2 (Day 7): Level 1 SD 0.64, Cv 0.04; Level 2 SD 0.59, Cv 0.02; Level 3 SD 0.59, Cv 0.01 | ||
| Alternate Site #3 (Day 1): Level 1 SD 0.51, Cv 0.03; Level 2 SD 0.88, Cv 0.02; Level 3 SD 1.11, Cv 0.02 | ||
| Alternate Site #3 (Day 7): Level 1 SD 0.68, Cv 0.04; Level 2 SD 0.51, Cv 0.02; Level 3 SD 0.52, Cv 0.01 | ||
| Laboratory (Day 1): Level A SD 0.32, Cv 0.02; Level B SD 0.48, Cv 0.02; Level C SD 0.48, Cv 0.02; Level D SD 0.58, Cv 0.01; Level E SD 0.68, Cv 0.01 | ||
| Laboratory (Day 13): Level A SD 0.52, Cv 0.04; Level B SD 0.67, Cv 0.02; Level C SD 0.92, Cv 0.02; Level D SD 1.51, Cv 0.02; Level E SD 0.52, Cv 0.01 | ||
| Precision (Between-Run) - Hematocrit | Not explicitly defined as acceptance criteria. | Physician Office #1: Level 1 SD 0.92, Cv 0.05; Level 2 SD 1.13, Cv 0.04; Level 3 SD 0.07, Cv |
§ 864.6400 Hematocrit measuring device.
(a)
Identification. A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.